Friday, September 16, 2016 1:41:36 PM
Thanks for the email. We have been clear that our ongoing Phase 2b trial will retain a placebo arm for the full 12 months. In Q3 we will report viral shedding rate reductions vs. placebo and baseline for the immediate post dosing observation period and around the end of the year we will be reporting our clinical efficacy data versus placebo at 6 months post dosing.
As you know the placebo arm in the dose optimization trial was included for comparative acute tolerability purposes only and it certainly is not new news that our 6 and 12 month data would not have a placebo comparator - this was entirely consistent with the primary endpoint of the trial, which was a change from baseline analysis in viral shedding - a standard way of measuring viral activity in genital herpes. The feedback which we receive from our investigators and experts in the field is that the weight of efficacy data which we have presented to date is compelling and they, and we, remain enthused about GEN-003's potential.
Jonathan Poole
Axis Technologies Group and Carbonis Forge Ahead with New Digital Carbon Credit Technology • AXTG • Apr 24, 2024 3:00 AM
North Bay Resources Announces Successful Equipment Test at Bishop Gold Mill, Inyo County, California • NBRI • Apr 23, 2024 9:41 AM
Epazz, Inc.: CryObo, Inc. solar Bitcoin operations will issue tokens • EPAZ • Apr 23, 2024 9:20 AM
Avant Technologies Launches Advanced AI Supercomputing Network and Expansive Data Solutions • AVAI • Apr 23, 2024 8:00 AM
BestGrowthStocks.com Issues Comprehensive Analysis of Triller Merger with AGBA Group Holding Limited • AGBA • Apr 22, 2024 1:00 PM
Cannabix Technologies to Present Marijuana Breathalyzer Technology at International Association for Chemical Testing (IACT) Conference in California • BLO • Apr 22, 2024 8:49 AM